Halitosis Devised Questionnaire Evaluating a New Treatment

Halitosis Clinical Trial

Official title:

Halitosis Devised Questionnaire Evaluating a New Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046812
• Other study ID #: SLR 09-141
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: October 5, 2015
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2009
• Source: New York Head & Neck Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators propose a novel assessment of oral malodor (halitosis) by a quality of life (QOL) questionnaire designed specifically for halitosis and a new treatment for halitosis by improvement of mouth dryness.

Description:

Halitosis is a common symptom which can affect people of all ages. It may decrease self confidence and social interactions. Oral halitosos is the consequence of microbial (mainly Gram negative bacteria) breakdown of food debris, cells, saliva, and blood. The agents that give rise to halitosis include especially the volatile sulphur compounds (VSC), diamines, and short chain fatty acids of which only the VSC can be detected in the clinical setting, making the detection of halitosis often very hard. The most common cause for oral halitosis is poor oral hygiene due to gingivitis or periodontitis. Other causes include bacterial accumulation on the posterior tongue, tonsillitis and others. Dry mouth has been implicated as a potential cause in halitosis.

Due to the lack of quantitative objective measuring to the severity of halitosis and especially in the face of the subjective nature of halitosis as occurs commonly a subjectively measurement is necessary. As no current QOL exists for measurement of halitosis formulation of such a questionnaire can enable a measurement of subjective halitosis with change observed over time or with intervention.

We intend to treat halitosis with a novel approach targeting mouth dryness- when other factors were ruled out by measuring outcome on the halitosis questionnaire.

We will treat mouth dryness with Caphosol- a solution indicated for mouth dryness acting only locally after mouth washing. As this is a supersaturated phosphate solution of a mineral not alien to the body side effects are practically negligible.

Quality of life (QOL) questionnaires (such as SNOT20- sinonasal outcome test) are common in medicine, however no such questionnaire exists for halitosis. We devised a specific QOL questionnaire for halitosis. This questionnaire consists of 20 questions covering functional limitation, physical discomfort, psychological discomfort, physical disability and social disability. The answers will be based on a common scale of 5 answers depending on the severity and ranging from a never bothering symptom to a symptom which as worse as can be. Formulation of this a questionnaire can assist in measuring subjective halitosis with change observed over time or with intervention.

Treating halitosis is a challenge due to the multitude of factors. However, some treatments, mainly in the form of nasal saline irrigation or oral solutions chlorine based or triclosan exist. Mouth dryness, although implicated as a factor, has not been targeted yet. Improving salivary flow may reduce the stasis of saliva thus reducing the concentration of proteins that bacteria dwell on as well as a better degradation of oral food debris.

Caphosol is a topical oral agent of supersaturated calcium phosphate rinse indicated for dry mouth that has been clinically proven to shorten the duration and severity of mucositis and relieve dry mouth when used with fluoride. Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. It has an extremely high safety profile as these salts are not alien to the body, thus if swallowed accidentally, no adverse effects are expected. No known drug interactions exist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients complaining of halitosis

• Patients over 18

• Patients with dry mouth as seen on physical examinations

• Patients that may be suffering from Sjogren's syndrome will be screened by SSB/La blood test.

Exclusion Criteria:

• Patients without any other noted causes contributing to halitosis.

• Patients restricted to a low sodium diet without specific permission from the treating physician.

• Patients not wishing to participate in the study will be asked to fill the questionnaire regardless

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Halitosis

Intervention

Drug:
• Caphosol
Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.

Locations

Country	Name	City	State
United States	New York Head & Neck Institute offices	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Head & Neck Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Koshimune S, Awano S, Gohara K, Kurihara E, Ansai T, Takehara T. Low salivary flow and volatile sulfur compounds in mouth air. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Jul;96(1):38-41. — View Citation

Porter SR, Scully C. Oral malodour (halitosis). BMJ. 2006 Sep 23;333(7569):632-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Caphosol in treating Halitosis		1 month	Yes
Secondary	Confirmation of QOL questionnaire as tool measuring the burden of halitosis		1 month	No

External Links

•   New York Head & Neck Institute